Indo-German Expert Exchange on Medical Devices and Equipment

Standardisation plays an important role in ensuring the safety and reliability of medical devices and equipment. The corona pandemic underlines how important quality aspects in this field are. It also shows the relevance of international harmonisation. It helps to increase the accessibility to essential products. Thereby, it can improve the capacity to respond to public health crises.

Experts from the Bureau of Indian Standards (BIS), the German Institute for Standardization (DIN) and the German Commission for Electrical, Electronic & Information Technologies of DIN and VDE (DKE) discussed current topics and priorities in standardisation of medical devices and equipment on 3 September 2020.

Mr J. Roy Chowdhury, Deputy Director General of BIS, emphasised the relevance of Indo-German cooperation on medical devices and equipment against the background of the current pandemic challenges and recent regulatory developments in this field.

Ms Christine Rümenapp from Siemens Healthineers outlined relevant aspects from the perspective of the industry on standardisation of in vitro diagnostic (IVD) devices. She highlighted the need for technology neutral standards in the field of IVD, which may be applied across a wide range of device types. Technology neutral standards play a key role in supporting innovation and ensuring market access for start-ups and smaller companies, she said.

Both sides agreed to continue the exchange on the design of IVD standards. The participants identified assistive products, health informatics and electrical equipment in medical practice as areas for cooperation within the Indo-German Working Group on Quality Infrastructure and at international level. They also concluded to continue the exchange on priority topics in the light of the corona pandemic, such as personal protective equipment (PPE).

The Indo-German Working Group on Quality Infrastructure was established by the German Federal Ministry for Economic Affairs and Energy (BMWi) and the Indian Ministry for Consumer Affairs, Food & Public Distribution (MoCAF&PD). It serves as a platform to jointly develop positions and solutions for international technical harmonisation. As part of the Global Project Quality Infrastructure (GPQI) of BMWi, GIZ – the German Agency for International Cooperation – has been commissioned by BMWi to support the implementation of the activities of the Working Group in India.